What side effects are associated with this type of intervention?

Common treatments for bowel incontinence include electrical stimulation, sacral nerve stimulation (SNS), and topical pharmacologic agents. Electrical stimulation may provide short-term benefits but lacks long-term data. SNS is associated with significant reductions in incontinence episodes but can have side effects such as pain at the implant site and infection. Topical pharmacologic agents like phenylephrine may alter neural sphincter control but specific side effects are not well-documented. Intravaginal estrogen therapy, aimed at improving tissue quality and wound healing, may cause local irritation, discharge, and systemic hormonal effects. Overall, side effects vary by treatment type and individual patient response.

What prior FDA approvals exist?

Injectable bulking agents such as dextranomer in stabilized hyaluronic acid are used for the treatment of bowel incontinence. These agents are administered in an outpatient setting and help improve tissue quality and function by providing bulk to the anorectal region. While specific FDA approval details are not provided, these treatments are clinically utilized and marketed to gastroenterologists and surgeons for managing fecal incontinence.

What other types of research exist?

Promising novel alternatives to intravaginal estrogen therapy for bowel incontinence include: 1) Intrasphincteric injections of autologous myoblasts, which aim to regenerate damaged sphincter muscles, 2) Sacral nerve stimulation, which is an evolving treatment for patients who do not respond to other therapies, and 3) Surgical options such as bowel resection or nodule excision for endometriosis-related incontinence. These alternatives offer varying degrees of invasiveness and potential benefits.

← Back to Search

Estrogen

Vaginal Estrogen Cream for Postpartum Recovery

Phase 4

Recruiting

Led By Hannah L Chapman, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be able to self apply vaginal cream

Aged 18 years or older

Must not have

Contraindications to intra-vaginal estrogen therapy (spontaneous DVT, stroke, hormone responsive breast cancer)

Allergy to estradiol vaginal cream 0.01% or its constituents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months postpartum

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether applying estrogen cream inside the vagina can help women who have had severe tears during childbirth. These women often have problems like pain during sex and incontinence. The estrogen cream aims to improve tissue healing and reduce these symptoms.

Who is the study for?

This trial is for women aged 18 or older who have experienced severe tears during childbirth (3rd or 4th degree lacerations) and can apply vaginal cream themselves. It's not suitable for those with a history of blood clots, stroke, hormone-sensitive breast cancer, tobacco use, allergies to estradiol cream or its ingredients, or if they have an infection at the site of injury.

What is being tested?

The study tests whether applying a topical vaginal estrogen cream (Estradiol 0.01%) after childbirth helps with recovery from obstetric anal sphincter injuries compared to a placebo cream. The focus is on improving sexual function and reducing distress from urinary and bowel incontinence.

What are the potential side effects?

Potential side effects may include local irritation where the cream is applied, hormonal changes that could affect mood or periods, and possibly increased risk of blood clots although this risk is generally lower with topical application than other forms of estrogen therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can apply vaginal cream by myself.

Select...

I am 18 years old or older.

Select...

I have experienced severe tearing during childbirth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot use intra-vaginal estrogen due to a history of DVT, stroke, or hormone-sensitive breast cancer.

Select...

I am allergic to estradiol vaginal cream or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

sexual dysfunction symptom severity

Secondary study objectives

Anal incontinence

Urinary incontinence

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Topical vaginal estrogen groupActive Control1 Intervention

Estradiol vaginal cream 0.01% 1g will be administered vaginally, initiated at 2 weeks postpartum and continued until 6 months postpartum. Beginning at 2 weeks postpartum, 1g estradiol vaginal cream 0.01% will be administered by participants nightly for 2 weeks then twice weekly to complete 6 months therapy

Group II: Placebo groupPlacebo Group1 Intervention

Placebo cream, 1g will be administered vaginally, initiated at 2 weeks postpartum and continued until 6 months postpartum. Beginning at 2 weeks postpartum, 1g of placebo cream will be administered by participants nightly for 2 weeks then twice weekly to complete 6 months therapy.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bowel incontinence include anal bulking agents, endoanal electrical stimulation with biofeedback, and estrogen therapy. Anal bulking agents work by injecting materials into the anal canal to improve the closure of the sphincter, thereby reducing incontinence episodes. Endoanal electrical stimulation with biofeedback helps strengthen the pelvic floor muscles and improve sphincter control through targeted electrical impulses and real-time feedback. Estrogen therapy, particularly intravaginal estrogen, improves tissue quality and wound healing by addressing estrogen deficiency, which is crucial for maintaining the integrity of the pelvic floor and anal sphincter. These treatments are important for bowel incontinence patients as they target the underlying mechanisms of sphincter dysfunction and tissue quality, thereby improving continence and quality of life.

Administration of an Anal Bulking Agent With Polyacrylate-Polyalcohol Copolymer Particles Versus Endoanal Electrical Stimulation With Biofeedback for the Management of Mild and Moderate Anal Incontinence: A Randomized Prospective Study.Systematic Review of Surgical Treatments for Fecal Incontinence.The influence of oestrogen replacement on faecal incontinence in postmenopausal women.