Pelvic Organ ProlapsePhase 4IMPROVENCT02431897

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

A Phase 4 study testing Conjugated Estrogens Cream in people with Pelvic Organ Prolapse and Urogenital Prolapse, run by University of Texas Southwestern Medical Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 48 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse
What is being tested?: Conjugated Estrogens Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 206 participants
Where: 3 sitesUnited States
Study dates: Dec 2016to 17 May 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 48 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal: no menses for >1 year
Minimum age: 48 years
Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
Medically fit for elective surgery
Physically able to apply/insert the study drug
Available for clinic follow-up for minimum 1yr

Who cannot join

Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
BMI >35 kg/m2
Recent history (within last month) of vaginal infection or vaginitis
Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
History of connective tissue disease
Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu

Show all 10Show fewer

History of vaginal irradiation
Allergy to Premarin or its constituents
Prior apical repair or use of mesh for prolapse repair
Current tobacco use

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905

Other trials in United States

About this study

This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.

Read the detailed description

This is a double-blind randomized trial of intravaginal estrogen (conjugated estrogens, 0.625mg/1g cream) vs. placebo in postmenopausal women (up to n=222 enrolled and randomized in order for 188 to undergo surgery) with symptomatic prolapse beyond the hymen planning transvaginal native tissue repairs. Medication will be started >5 weeks before surgery and continued for 1 year postoperatively, i.e. until scar remodeling is complete. The investigators aim to determine if pre- and postoperative intravaginal estrogen therapy (i) results in anatomic and patient-reported subjective improvement in pelvic organ support, and (ii) impacts other pelvic floor disorders (overactive bladder and incontinence, sexual function and pain, postoperative cystitis), satisfaction, quality of life, and vaginal wound healing. Finally, (iii) the investigators will determine the potential mechanisms by which local estrogen treatment alters pelvic organ support by examining full-thickness vaginal wall biopsies taken at the time of surgery for histologic, connective tissue, and smooth muscle synthesis and degradative changes. The investigators expect this will highlight other novel targets for future therapies in prolapse repair and prevention.

Conditions: Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse, Vaginal Prolapse
Being tested: Conjugated Estrogens Cream, Placebo Cream
Keywords: Pelvic Organ Prolapse, Pelvic Floor Disorders, Therapy, Estrogen Replacement, Estrogens, Conjugated
Medical subject headings: Pelvic Organ Prolapse, Cystocele, Uterine Prolapse, Pelvic Floor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conjugated Estrogens CreamDrug
Also called Premarin Vaginal Cream
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo CreamDrug
1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.

Study groups in NCT02431897
Study group	Role	What they receive
Estrogen Cream	Experimental	Conjugated Estrogens cream Receives: Drug: Conjugated Estrogens Cream
Placebo Cream	Placebo comparator	Placebo cream Receives: Drug: Placebo Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse
Cumulative failures, as measured by (i) anatomic assessment of prolapse, (ii) presence of bulge symptoms, and/or (iii) retreatment of pelvic organ prolapse
Measured: 12 months

Secondary outcomes (10)

Condition Specific (i.e. Pelvic Organ Prolapse) Symptom Bother as Measured by Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire
Questionnaire score at 12 months in overall condition-specific symptom bother as measured by Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire, which is scored from 0-300, higher scores being worse (i.e., more distressing)
Measured: 12 months
Condition Specific (i.e. Pelvic Organ Prolapse) Quality of Life as Measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Questionnaire score at 12 months in overall condition-specific quality of life as measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7) questionnaire, which is scored from 0-300, higher scores being worse (i.e., more distressing)
Measured: 12 months
Generic Quality of Life as Measured by SF-12 Questionnaire
Generic (physical component) quality of life as measured by SF-12 questionnaire at 12 months. Scores range from 0-100, with higher scores indicating better physical functioning; the US population average is 50 points.
Measured: 12 months
Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire, i.e. the Urinary Distress Inventory, UDI-6
Urinary symptom bother as measured by urinary subscale questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire, i.e. the Urinary Distress Inventory, UDI-6. This is scored from 0-100, with greater scores indicating greater symptom bother.
Measured: Time of surgery
Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire, i.e. the Urinary Distress Inventory, UDI-6
Urinary symptom bother as measured by urinary subscale questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire, i.e. the Urinary Distress Inventory, UDI-6. This is scored from 0-100, with greater scores indicating greater symptom bother.
Measured: 12 months
Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire
Urinary symptom impact on quality of life as measured by urinary subscale questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire. This is scored from 0-100, with greater scores indicating worse impact on quality of life.
Measured: Time of surgery
Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire
Urinary symptom impact on quality of life as measured by urinary subscale questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire. This is scored from 0-100, with greater scores indicating worse impact on quality of life.
Measured: 12 months
Sexual Function as Measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Sexual function in sexually-active women as measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The score ranges from 1 (worse sexual experience) to 5 (better sexual experience) with midrange scores commonly seen in women with pelvic floor disorders.
Measured: Time of surgery
Sexual Function as Measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Sexual function in sexually-active women as measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The score ranges from 1 (worse sexual experience) to 5 (better sexual experience) with midrange scores commonly seen in women with pelvic floor disorders.
Measured: 12 months
Number of Participants With Adverse Events
Number of participants reporting any adverse events from baseline randomization to 12 months postoperatively
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201617 May 2023

First posted1 May 2015 (estimated)
Study startDec 2016
Primary completion29 Nov 2021
Study completion17 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02431897
Sponsor's protocol ID: STU 022015-117
Acronym: IMPROVE
Status last verified: Aug 2023
First submitted: 23 Apr 2015
Last updated: 6 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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 Recurrence of the Vagina using Estrogen: IMPROVE). Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e227-e233. doi: 10.1097/SPV.0000000000000899.
PubMed 32541299
Rahn DD, Richter HE, Sung VW, Pruszynski JE. Three-year outcomes of a randomized clinical trial of perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair. Am J Obstet Gynecol. 2024 Aug;231(2):263.e1-263.e10. doi: 10.1016/j.ajog.2024.04.042. Epub 2024 May 4.
PubMed 38710269
Rahn DD, Richter HE, Sung VW, Hynan LS, Pruszynski JE. Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair. Obstet Gynecol. 2024 Feb 1;143(2):312-319. doi: 10.1097/AOG.0000000000005478. Epub 2023 Dec 7.
PubMed 38061041
Rahn DD, Richter HE, Sung VW, Pruszynski JE, Hynan LS. Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial. JAMA. 2023 Aug 15;330(7):615-625. doi: 10.1001/jama.2023.12317.
PubMed 37581673
Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
PubMed 37431855
Rahn DD, Richter HE, Sung VW, Hynan LS, Pruszynski JE. Effects of preoperative intravaginal estrogen on pelvic floor disorder symptoms in postmenopausal women with pelvic organ prolapse. Am J Obstet Gynecol. 2023 Sep;229(3):309.e1-309.e10. doi: 10.1016/j.ajog.2023.05.023. Epub 2023 May 25.
PubMed 37244454

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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Recruiting
Pelvic Floor Muscle Training During Pregnancy
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Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
ClinicalTrials.gov ID: NCT02431897
Acronym / sponsor ID: IMPROVE / STU 022015-117
Conditions: Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse, Vaginal Prolapse
Keywords: Pelvic Organ Prolapse, Pelvic Floor Disorders, Therapy, Estrogen Replacement, Estrogens, Conjugated
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 206 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: University of Alabama at Birmingham, Women and Infants Hospital of Rhode Island, Pfizer
Study start: Dec 2016 (actual)
Primary completion: 29 Nov 2021 (actual)
Study completion: 17 May 2023 (actual)
First posted: 1 May 2015 (estimated)
Results: Posted 16 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Estrogen Cream	Experimental	Drug: Conjugated Estrogens CreamConjugated Estrogens cream
Placebo Cream	Placebo comparator	Drug: Placebo CreamPlacebo cream

Who may qualify

Ages: 48 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Postmenopausal: no menses for >1 year
Minimum age: 48 years
Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
Medically fit for elective surgery

Key exclusion criteria (10 listed)

Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
BMI >35 kg/m2
Recent history (within last month) of vaginal infection or vaginitis
Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
History of connective tissue disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Conjugated Estrogens CreamAlso: Premarin Vaginal Cream0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.	Drug	Estrogen Cream
Placebo Cream1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.	Drug	Placebo Cream

Primary outcome

Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse
Time frame: 12 months
Cumulative failures, as measured by (i) anatomic assessment of prolapse, (ii) presence of bulge symptoms, and/or (iii) retreatment of pelvic organ prolapse

10 secondary outcomes

Condition Specific (i.e. Pelvic Organ Prolapse) Symptom Bother as Measured by Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire
Time frame: 12 months
Condition Specific (i.e. Pelvic Organ Prolapse) Quality of Life as Measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Time frame: 12 months
Generic Quality of Life as Measured by SF-12 Questionnaire
Time frame: 12 months
Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire, i.e. the Urinary Distress Inventory, UDI-6
Time frame: Time of surgery
Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire, i.e. the Urinary Distress Inventory, UDI-6
Time frame: 12 months
Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire
Time frame: Time of surgery
Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire
Time frame: 12 months
Sexual Function as Measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Time frame: Time of surgery
Sexual Function as Measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Time frame: 12 months
Number of Participants With Adverse Events
Time frame: 12 months

Results and safety

Results posted to the registry on 16 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Estrogen Cream	102	93
Placebo Cream	97	93

Primary outcome: Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Estrogen Cream n = 93	Placebo Cream n = 93
Value	18	8

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline randomization to 12 months postoperatively. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Estrogen Cream	10 of 102 (9.8%)	56 of 102 (54.9%)	0 of 102
Placebo Cream	11 of 97 (11.3%)	51 of 97 (52.6%)	0 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32541299Rahn 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 Recurrence of the Vagina using Estrogen: IMPROVE). Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e227-e233. doi: 10.1097/SPV.0000000000000899.
Derived from this study: PubMed 38710269Rahn DD, Richter HE, Sung VW, Pruszynski JE. Three-year outcomes of a randomized clinical trial of perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair. Am J Obstet Gynecol. 2024 Aug;231(2):263.e1-263.e10. doi: 10.1016/j.ajog.2024.04.042. Epub 2024 May 4.
Derived from this study: PubMed 38061041Rahn DD, Richter HE, Sung VW, Hynan LS, Pruszynski JE. Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair. Obstet Gynecol. 2024 Feb 1;143(2):312-319. doi: 10.1097/AOG.0000000000005478. Epub 2023 Dec 7.
Derived from this study: PubMed 37581673Rahn DD, Richter HE, Sung VW, Pruszynski JE, Hynan LS. Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial. JAMA. 2023 Aug 15;330(7):615-625. doi: 10.1001/jama.2023.12317.
Derived from this study: PubMed 37431855Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
Derived from this study: PubMed 37244454Rahn DD, Richter HE, Sung VW, Hynan LS, Pruszynski JE. Effects of preoperative intravaginal estrogen on pelvic floor disorder symptoms in postmenopausal women with pelvic organ prolapse. Am J Obstet Gynecol. 2023 Sep;229(3):309.e1-309.e10. doi: 10.1016/j.ajog.2023.05.023. Epub 2023 May 25.

Related trials for Pelvic Organ Prolapse

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David D Rahn, MD principal investigator

University of Texas Southwestern Medical Center

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Conjugated Estrogens Cream in people with Pelvic Organ Prolapse and Urogenital Prolapse, run by University of Texas Southwestern Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02431897, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.