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Review
. 2023 Jul 11;7(7):CD014592.
doi: 10.1002/14651858.CD014592.pub2.

Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women

Annika Taithongchai  1 , Eugenie E Johnson  2   3 , Sharif I Ismail  4 , Evelyn Barron-Millar  5 , Ashleigh Kernohan  2 , Ranee Thakar  6
Affiliations
Review

Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women

Annika Taithongchai et al. Cochrane Database Syst Rev. .

Abstract

Background: Pelvic organ prolapse (POP) is the descent of a woman's uterus, bladder, or rectum into the vagina. It affects 50% of women over 50 years old who have given birth to at least one child, and recognised risk factors are older age, higher number of births, and higher body mass index. This review assesses the effects of oestrogen therapy, alone or in combination with other treatments, on POP in postmenopausal women.

Objectives: To assess the benefits and harms of local and systemic oestrogen therapy in the management of pelvic organ prolapse symptoms in postmenopausal women, and to summarise the principal findings of relevant economic evaluations.

Search methods: We searched the Cochrane Incontinence Specialised Register (up to 20 June 2022), which includes CENTRAL, MEDLINE, two trials registers, and handsearching of journals and conference proceedings. We also checked the reference lists of relevant articles for additional studies.

Selection criteria: We included randomised controlled trials (RCTs), quasi-RCTs, multi-arm RCTs, and cross-over RCTs that evaluated the effects of oestrogen therapy (alone or in combination with other treatments) versus placebo, no treatment, or other interventions in postmenopausal women with any grade of POP.

Data collection and analysis: Two review authors independently extracted data from the included trials using prespecified outcome measures and a piloted extraction form. The same review authors independently assessed the risk of bias of eligible trials using Cochrane's risk of bias tool. Had data allowed, we would have created summary of findings tables for our main outcome measures and assessed the certainty of the evidence using GRADE.

Main results: We identified 14 studies including a total of 1002 women. In general, studies were at high risk of bias in terms of blinding of participants and personnel, and there were also some concerns about selective reporting. Owing to insufficient data for the outcomes of interest, we were unable to perform our planned subgroup analyses (systemic versus topical oestrogen, parous versus nulliparous women, women with versus without a uterus). No studies assessed the effects of oestrogen therapy alone versus no treatment, placebo, pelvic floor muscle training, devices such as vaginal pessaries, or surgery. However, we did identify three studies that assessed oestrogen therapy in conjunction with vaginal pessaries versus vaginal pessaries alone and 11 studies that assessed oestrogen therapy in conjunction with surgery versus surgery alone.

Authors' conclusions: There was insufficient evidence from RCTs to draw any solid conclusions on the benefits or harms of oestrogen therapy for managing POP symptoms in postmenopausal women. Topical oestrogen in conjunction with pessaries was associated with fewer adverse vaginal events compared with pessaries alone, and topical oestrogen in conjunction with surgery was associated with reduced postoperative urinary tract infections compared with surgery alone; however, these findings should be interpreted with caution, as the studies that contributed data varied substantially in their design. There is a need for larger studies on the effectiveness and cost-effectiveness of oestrogen therapy, used alone or in conjunction with pelvic floor muscle training, vaginal pessaries, or surgery, for the management of POP. These studies should measure outcomes in the medium and long term.

Trial registration: ClinicalTrials.gov NCT02906111 NCT03779633 NCT00803335 NCT03032848 NCT02431897 NCT04393194.

PubMed Disclaimer

Conflict of interest statement

In accordance with Cochrane's Commercial Sponsorship Policy, the following declarations are applicable for the three years prior to the publication date of this review.

AT: none known EEJ: is Assistant Managing Editor for Cochrane Incontinence. She did not take any part in the editorial process for this review. SII: none known EBM: none known AK: is an Editor with Cochrane. She did not take any part in the editorial process for this review. RT: none known

Figures

1
1
PRISMA diagram – clinical effectiveness searches.
2
2
PRISMA diagram – cost effectiveness searches.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.2
1.2. Analysis
Comparison 1: Oestrogen therapy (OT) in conjunction with vaginal pessaries versus vaginal pessaries alone, Outcome 2: Reduction in minor adverse events: vaginal events
2.7
2.7. Analysis
Comparison 2: Oestrogen therapy (OT) in conjunction with surgery versus surgery alone, Outcome 7: Improvement or cure of associated sexual symptoms: 6 months
2.8
2.8. Analysis
Comparison 2: Oestrogen therapy (OT) in conjunction with surgery versus surgery alone, Outcome 8: Improvement or cure of associated sexual symptoms: 12 months
2.9
2.9. Analysis
Comparison 2: Oestrogen therapy (OT) in conjunction with surgery versus surgery alone, Outcome 9: Objective improvement or cure of pelvic organ prolapse: 6 months (meta‐analysis)
2.14
2.14. Analysis
Comparison 2: Oestrogen therapy (OT) in conjunction with surgery versus surgery alone, Outcome 14: Participant adherence to intervention (meta‐analysis)
2.16
2.16. Analysis
Comparison 2: Oestrogen therapy (OT) in conjunction with surgery versus surgery alone, Outcome 16: Reduction in minor adverse events: urinary tract infection
2.17
2.17. Analysis
Comparison 2: Oestrogen therapy (OT) in conjunction with surgery versus surgery alone, Outcome 17: Reduction in minor adverse events: vaginal events
2.18
2.18. Analysis
Comparison 2: Oestrogen therapy (OT) in conjunction with surgery versus surgery alone, Outcome 18: Reduction in minor adverse events: urinary storage events
2.20
2.20. Analysis
Comparison 2: Oestrogen therapy (OT) in conjunction with surgery versus surgery alone, Outcome 20: Major adverse events: total number of events
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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    1. NCT02906111. Vaginal estriol before and vaginal surgery for prolapse (VSaE) [Effects on vaginal health and quality of life in postmenopausal women using ultra low topic estriol before vaginal surgery for pelvic statics disorders]. clinicaltrials.gov/show/NCT02906111 (first received 19 September 2016).
Chiengthong 2022 {published data only}
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    1. TCTR20180329001. Effect of vaginal estriol 0.03 mg with Lactobacillus acidophilus on incidence of bacterial vaginosis in patient using pessary for treatment of pelvic organ prolapse. thaiclinicaltrials.org/show/TCTR20180329001 (first received 29 March 2018).
Coelho 2020 {published data only}
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Felding 1992 {published data only}
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Karp 2012 {published data only}
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Marschalek 2021 {published data only}
    1. EUCTR2016-000410-30-AT. Preoperative locally applied oestrogen in postmenopausal women with pelvic organ prolapse: influence on subjective and objective parameters [Preoperative locally applied oestrogen in postmenopausal women with pelvic organ prolapse: changes in subjective and objective outcome: a prospective randomized, double-blind, placebo-controlled study]. www.clinicaltrialsregister.eu/ctr-search/trial/2016-000410-30/results (first received 19 October 2016).
    1. Marschalek ML, Bodner K, Kimberger O, Morgenbesser R, Dietrich W, Obruca C, et al. Sexual function in postmenopausal women with symptomatic pelvic organ prolapse treated either with locally applied estrogen or placebo: results of a double-masked, placebo-controlled, multicenter trial. Journal of Sexual Medicine 2022;19(7):1124-30. [DOI: 10.1016/j.jsxm.2022.04.007] - DOI - PubMed
    1. Marschalek ML, Bodner K, Kimberger O, Morgenbesser R, Dietrich W, Obruca C, et al. Surgical assessment of tissue quality during pelvic organ prolapse repair in postmenopausal women pre-treated either with locally applied estrogen or placebo: results of a double-masked, placebo-controlled, multicenter trial. Journal of Clinical Medicine 2021;10(11):2531. [DOI: 10.3390/jcm10112531] - DOI - PMC - PubMed
    1. Marschalek ML, Bodner K, Kimberger O, Zehetmayer S, Mordenbesser R, Dietrich W, et al. Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study. BJOG 2021;128(13):2200-8. [DOI: 10.1111/1471-0528.16894] - DOI - PMC - PubMed
    1. NCT03779633. Preoperative oestrogen in postmenopausal women with pelvic organ prolapse [Preoperative locally applied oestrogen in postmenopausal women with pelvic organ prolapse: changes in subjective and objective outcome – a prospective, randomized, double-blind, placebo-controlled, multicenter study]. clinicaltrials.gov/show/NCT03779633 (first received 19 December 2018).
Nunes 2011 {published data only}
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Rahn 2014 {published data only}
    1. Good MM, Shi H, Keller P, Roshanravan SM, Word A, Rahn DD. Local estrogen treatment prior to pelvic reconstructive surgery decreases collagenases and elastases in the vaginal wall: a double-blind randomized controlled study in postmenopausal women with prolapse (Abstract 06). Female Pelvic Medicine and Reconstructive Surgery 2013;19(Suppl 5):S47. [DOI: 10.1097/SPV.0b013e3182a5ddf0] - DOI
    1. Good MM, Wai C, Schaffer JI, Corton MM, White A, Shi H, et al. Patient compliance & safety with use of preoperative local estrogen treatment in postmenopausal women with prolapse: Analysis from a double-blind randomized controlled study (Abstract 15). Female Pelvic Medicine and Reconstructive Surgery 2013;19(Suppl 5):S85. [DOI: 10.1097/SPV.0b013e3182a5ddf0] - DOI
    1. NCT01778985. Effect of preoperative estrogen treatment on connective tissues of the pelvic floor (PET) [Effect of preoperative estrogen treatment on connective tissues of the pelvic floor]. clinicaltrials.gov/show/NCT01778985 (first received 29 January 2013).
    1. Rahn DD, Good MM, Roshanravan SM, Shi H, Schaffer JI, Singh RJ, et al. Effects of preoperative local estrogen in postmenopausal women with prolapse: a randomized trial. Journal of Clinical Endocrinology and Metabolism 2014;99(10):3728-36. [DOI: 10.1210/jc.2014-1216] - DOI - PMC - PubMed
    1. Rahn DD, Good MM, Shi H, Keller P, Roshanravan SM, Word A. Effects of preoperative local estrogen treatment on connective tissues of the vaginal wall in postmenopausal women with prolapse: a double-blind randomized controlled study (Abstract 05). Female Pelvic Medicine and Reconstructive Surgery 2013;19(Suppl 5):S47. [DOI: 10.1097/SPV.0b013e3182a5ddf0] - DOI
Stipic 2012 {published data only}
    1. Stipic I, Polasek O, Vulic M, Punda H, Grandic L, Strinic T. Estrogen replacement therapy improves pulmonary function in postmenopausal women with genital prolapse. Rejuvenation Research 2012;15(6):596-600. [DOI: 10.1089/rej.2012.1337] - DOI - PubMed
Sun 2016 {published data only}
    1. Sun Z, Zhu L, Xu T, Shi X, Lang J. Effects of preoperative vaginal estrogen therapy for the incidence of mesh complication after pelvic organ prolapse surgery in postmenopausal women: is it helpful or a myth? A 1-year randomized controlled trial. Menopause 2016;23(7):740-8. [DOI: 10.1097/GME.0000000000000614] - DOI - PubMed
    1. Zhu L, Sun Z, ChiCTR-TRC-13003481. A Randomized, controlled trial of intravaginal promestriene in women with a risk of mesh exposure associated with transvaginal implantation for pelvic organ prolapse [阴道局部应用雌激素对预防网片重建手术网片暴露的效果研究]. chictr.org.cn/showproj.aspx?proj=6079 (first received 15 August 2013).
Tontivuthikul 2016 {published data only}
    1. Tontivuthikul P, Sanmee U, Wongtra-Ngan S, Pongnarisorn C. Effect of local estrogen cream on vaginal health after pessary use for prolapsed pelvic organ: a randomized controlled trial. Journal of the Medical Association of Thailand 2016;99(7):757-63. - PubMed
Vaccaro 2013 {published data only}
    1. NCT00803335. The effects of local vaginal estrogen in postmenopausal women with pelvic organ prolapse [The effects of local vaginal estrogen in postmenopausal women with pelvic organ prolapse: a randomized control trial]. clinicaltrials.gov/ct2/show/NCT00803335 (first received 05 December 2008).
    1. Vaccaro CM, Crisp CC, Estanol MV, Fellner AN, Mutema GK, Kleeman SD, et al. Administration of vaginal estrogen in women with vaginal atrophy prior to prolapse surgery: an assessment of quality of life outcomes and medication adherence (Abstract 286). International Urogynecology Journal 2011;22(Suppl 3):S1839-40. [DOI: 10.1007/s00192-011-1521-1] - DOI
    1. Vaccaro CM, Crisp CC, Fellner AN, Pauls RN. Impact of preoperative vaginal estrogen on patient quality of life measures: a randomized controlled trial (Abstract 120). Female Pelvic Medicine and Reconstructive Surgery 2012;18(8 Suppl 1):S151-2. [DOI: 10.1097/SPV.0b013e31826abf55] - DOI
    1. Vaccaro CM, Mutema GK, Fellner AN, Crisp CC, Estanol MV, Kleeman SD, et al. Histologic and cytologic effects of vaginal estrogen in women with pelvic organ prolapse: a randomized controlled trial. Female Pelvic Medicine and Reconstructive Surgery 2013;19(1):34-9. [DOI: 10.1097/SPV.0b013e318278cc40] - DOI - PubMed
    1. Vaccaro CM, Mutema GK, Fellner AN, Crisp CC, Pauls RN. The effects of vaginal estrogen in women with pelvic organ prolapse: a randomized controlled trial (Abstract 02). Female Pelvic Medicine and Reconstructive Surgery 2012;18(2 Suppl 1):S14. [DOI: 10.1097/SPV.0b013e31824bf52d] - DOI - PubMed
Verghese 2020 {published data only}ISRCTN46661996
    1. EudraCT2014-000179-18. Local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS) [Local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS) – feasibility study]. www.clinicaltrialsregister.eu/ctr-search/trial/2014-000179-18/results (first received 10 March 2015). - PMC - PubMed
    1. ISRCTN46661996. Local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery [Local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS) feasibility study]. isrctn.com/ISRCTN46661996 (first received 28 May 2015).
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References to studies excluded from this review

Barber 2002 {published data only}
    1. Barber MD, Visco AG, Wyman JF, Fantl JA, Bump RC, on behalf of the Continence Program for Women Research Group. Sexual function in women with urinary incontinence and pelvic organ prolapse. Obstetrics and Gynecology 2002;99(2):281-9. - PubMed
Chinthakanan 2019 {published data only}
    1. Chinthakanan O, Wattanayingcharoenchai R, Aimjirakul K, Sarit-Apirak S, Manonai J. Comparison of vaginal moisturizers with ultralow dose estriol & lactobacilluls acidophilus vaginaltablets in pelvic organ prolapse women who were treated with vaginal pessary: a randomized controlled trial (Abstract 144). International Urogynecology Journal 2019;30(Suppl 1):S168. [DOI: 10.1007/s00192-019-04125-2] - DOI
    1. Chinthakanan O, Wattanayingcharoenchai R, Aimjirakul K, Sarit-apirak S, Manonai J. Comparison of vaginal moisturizers with ultra-low dose estriol & lactobacilluls acidophilus vaginal tablets in pelvic organ prolapse women whowere treated with vaginal pessary: a randomized controlled trial (Scientific Salon 144). Female Pelvic Medicine and Reconstructive Surgery 2019;25(5 Suppl 1):S142. [DOI: 10.1097/SPV.0000000000000767] - DOI
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Chou 2013 {published data only}
    1. NCT01843166. Vaginal estrogen with pessary treatment [Use of vaginal estrogen with pessary treatment of pelvic organ prolapse and urinary incontinence]. clinicaltrials.gov/show/NCT01843166 (first received 30 April 2013).
Jiang 2017 {published data only}
    1. Jiang G, Zhu T, Zhou Y, Ma Q. Effect of puerarin on vaginal connective tissue in patients with pelvic organ prolapse. International Journal of Clinical and Experimental Medicine 2017;10(1):732-8.
Lind 2014 {published data only}
    1. NCT02316249. Vaginal creams to reduce vaginal erosion in pessary users [Vaginal creams for reduction of vaginal discharge and erosion in patients using ring with support or gellhorn pessaries to reduce pelvic organ prolapse]. clinicaltrials.gov/show/NCT02316249 (first received 12 December 2014).
Moalli 2012 {published data only}
    1. NCT01648751. Vaginal estrogen and pelvic floor physical therapy in women with symptomatic mild prolapse [Impact of vaginal estrogen in the treatment of symptomatic mild pelvic organ prolapse with pelvic floor physical therapy]. clinicaltrials.gov/show/NCT01648751 (first received 24 July 2012).
Paraiso 2020 {published data only}
    1. NCT02691936. Comparison of vaginal laser therapy to vaginal estrogen therapy (VeLVET) [A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause]. clinicaltrials.gov/ct2/show/NCT02691936 (first received 25 February 2016).
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References to studies awaiting assessment

Pinhat 2013 {published and unpublished data}
    1. NCT03032848. Vaginal estrogens comparative trial on pelvic organ prolapse patients [Randomized, blinded trial comparing vaginal estrogens on pelvic organ prolapse patients]. clinicaltrials.gov/show/NCT03032848 (first received 26 January 2017).
    1. Pinhat E. RE: Study query: Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients. Email to: E Johnson 18 January 2022.
    1. Pinhat EC. Estudo Comparativo De Cremes Estrogênicos Em Pacientes Com Prolapso Genital [Masters thesis] [Comparative Study of Estrogen Cream in Patients with Genital Prolapse. For information only, English title translated via Google Translate™]. Curitiba (Brazil): Universidade Federal do Paraná, 2017.
Vardy 2003 {published data only}
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Zhu 2014 {published data only}
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References to ongoing studies

Rahn 2021 {published data only}
    1. NCT02431897. Investigation to minimize prolapse recurrence of the vagina using estrogen (IMPROVE) [Investigation to minimize prolapse recurrence of the vagina using estrogen]. clinicaltrials.gov/show/NCT02431897 (first received 01 May 2015).
    1. Rahn DD, Richter HE, Sung VW, Larsen WI, Hynan LS. Design of a randomized clinical trial of perioperative vaginal estrogen versus placebo with transvaginal native tissue apical prolapse repair (investigation to minimize prolapse repair of the vagina using estrogen: IMPROVE). Female Pelvic Medicine and Reconstructive Surgery 2021;27(1):e227-33. [DOI: 10.1097/SPV.0000000000000899] - DOI - PMC - PubMed
Roovers 2018 {published data only}
    1. EUCTR2017-003144-21-NL. Research into effectiveness and costs concerning the use of (vaginally administered) oestrogen before and after vaginal prolapse surgery, in women after menopause [Onderzoek naar de effectiviteit en kosten van vaginale oestrogeencrème bij vrouwen na de menopauze die een verzakkingsoperatie ondergaan] [Cost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergoing prolapse surgery [Kosteneffectiviteit van perioperatief gebruik van topicale oestrogenen bij postmenopauzale vrouwen die vaginale prolapsoperatie ondergaan]]. www.clinicaltrialsregister.eu/ctr-search/trial/2017-003144-21/NL (first received 28 February 2018).
    1. NL6853, NTR7031. Research into effectiveness and costs concerning the use of oestrogen before and after vaginal prolapse surgery in women after menopause [Cost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergonig prolapse surgery]. trialregister.nl/trial/6853 [Dutch Trial Register (NTR) is undergoing redevelopment, information available via trialsearch.who.int/Trial2.aspx?TrialID=NTR7031] (first received 19 February 2018).
Vincent 2013 {published data only}
    1. NCT01886794. Hormonal status on blood flow and tissue in pelvic organ prolapse [Role of hormonal status on vascularization and vaginal tissue in women with pelvic organ prolapse]. clinicaltrials.gov/show/NCT01886794 (first received 26 June 2013).
Zhu 2020 {published data only}
    1. ChiCTR2000032753. The effect of intravaginal conjugated estrogen on ring pessary use for pelvic organ prolapse: a multicenter randomized, double- blind, placebo controlled, clinical trial [国产环型带膜子宫托联合使用阴道结合雌激素乳膏治疗女性症状性盆腔脏器脱垂的多中心的随机安慰剂对照双盲临床研究]. chictr.org.cn/hvshowproject.aspx?id=32555 (first received 24 March 2020).
    1. NCT04393194. The effect of intra-vaginal conjugated estrogen cream on ring pessary use for pelvic organ prolapse [The effect of intravaginal conjugated estrogen on ring pessary use for pelvic organ prolapse: a multicenter randomized, double- blind, placebo controlled, clinical trial]. clinicaltrials.gov/show/NCT04393194 (first received 19 May 2020).

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References to other published versions of this review

Taithongchai 2021
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